Class Class II
ceramys™ femoral head system (K241483)
Description
ceramys™ femoral head system by Encore Medical, L.P., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241483
Clearance Date2025-02-07
Clearance TypeTraditional
Product CodeLZO
Regulation Number888.3353
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241483
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. ceramys™ femoral head system (K241483) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K082844 | BIOLOX DELTA CERAMIC FEMORAL HEAD, BIOLOX DELTA CERAMIC FEM... | Encore Medical L.P. | 2008 |
| K072154 | FOUNDATION (FMP) POROUS COATED SPIKED ACETABULAR SYSTEM | Encore Medical L.P. | 2007 |
Trace the full predicate network for K241483
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.